MAUDE Adverse Event Report: ARTHREX, INC. GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MM; SMOOTH FIXATION PIN

Model Number	GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an anterior cruciate ligament reconstruction surgery the tip of the guide pin with suture eye ar-1297l is larger than 2.4 mm.Therefore the pin could not slide into the ar-1204f-24i insert 2.4 mm.3 pins with the same lot number were tested and all had the same problem.Another pin with a different lot number was used to finish the surgery.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation is not confirmed.Two unpackaged and two sealed packages of ar-1297ls guide pin with suture eye, 2.4 mm x 435 mm, sterile, serial/batch number (b)(6), were received for investigation.Functional testing does not apply to this device.A visual evaluation revealed that the pointy tip of the two unpackaged devices was bent.The critical dimensions of the unpackaged devices and one from the sealed package were measured according to drawing (b)(6), revision 24.¿ diameter: ø.096 ±.002; result:.096 for all three devices.¿ distance:.48 ±.03; results: device #1:.48, device #2:.48, device #3:.47.The received devices meet the specifications according to drawing (b)(6), revision 24.No problem found.

• Brand Name: GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MM
• Common Device Name: SMOOTH FIXATION PIN
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20199376
• Report Number: 1220246-2024-07544
• Device Sequence Number: 12430998
• Product Code: MDM
• UDI-Device Identifier: 00888867007239
• UDI-Public: 00888867007239
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GUIDE PIN W/ SUTURE EYE 2.4 MM X 435 MM
• Device Catalogue Number: AR-1297LS
• Device Lot Number: 15220879
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown